Study of Periodontal Tissues in Fixed Prostheses on Natural Teeth

When the tooth is severely compromised, it needs a prosthetic crown. The tooth is prepared to allow the housing of the prosthetic crown without difficulty. This study aims to compare two different types of preparations to see with which of the two the gingival tissue reacts best.

Study Overview

• Status: Unknown
• Conditions: Dental Prosthesis Failure; Tissue Injury; Dental Prosthesis Complication; Prosthetic Tissue Defect
• Intervention / Treatment: Procedure: crown preparation; Procedure: vertical preparation; Procedure: horizontal preparation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italy/MI
    • Milano, Italy/MI, Italy, 20123
      • Giulia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Need for restoration by single-tooth prosthetic crown, due to destructive caries, coronal fracture, endodontically treated tooth, severe abrasion, aesthetic problems, remake of old incongruous prosthetic crown, other complications.
2. If there are incongruous conservative restorations (composite fillings or other materials) in the elements adjacent to the tooth to be treated, these must be restored before the prosthetic therapy and must not be modified during the protocol.
3. Absence of active periodontal disease
4. over the age of 18;
5. periodontal probing less than 4 mm in the tooth to be treated
6. absence of bleeding on probing
7. full-mouth plaque score (FMPS) and full-mouth bleeding scores (FMBS) < 20% at the start of the study
8. Patients according to protocol participation and informed consent signature.

Exclusion Criteria:

1. contraindication to dental treatment
2. active periodontal disease
3. systemic diseases that may affect periodontitis
4. Pregnant women
5. Patients in orthodontic therapy
6. inability to return to the controls or to follow oral hygiene maintenance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vertical group	Procedure: crown preparation; includes tooth preparation; Procedure: vertical preparation; type of vertical preparation on the tooth that accepts the crown
Experimental: horizontal group	Procedure: crown preparation; includes tooth preparation; Procedure: horizontal preparation; type of horizontal preparation on the tooth that accepts the crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of gingival thickness	Gingival thickness (GT) measured in millimetres in the mid-buccal area of the tooth, at the central point between the gingival margin and the gingival mucus junction (MGJ) using an endodontic specillus with a silicone stop put in contact with the soft tissue until the specillus reaches the hard surface. At the time of the initial measurement of the periodontal parameters, i.e.	12 months
variation of gingival thickness digital	At the time of the initial measurement of the periodontal parameters, i.e. at the time 0 before the prosthetic preparation of the tooth element, a digital impression is taken in order to obtain a 3D image of the tissues around the tooth element to be rehabilitated.	The impression is taken before the final impression (t1), at 3 months (t2), 6 months (t3), 12 months (t4) and the 3D images are compared using software to evaluate the variation of the soft tissue.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOP	percentage of bleeding of the gingival sulcus of all dental elements using a millimeter periodontal probe	TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)
PPD	probing depth (PD), recorded in millimetres at 6 points for each tooth using a millimeter periodontal probe	TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)
Recessions	relative gingival recession (rREC), measured at 6 points for each tooth as the distance from the gingival margin (GM) to the apical edge of the acrylic template previously using a millimeter periodontal probe	TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)
aesthetic value	Aesthetic evaluation of soft tissue is performed with the Pink Aesthetic Score/White Aesthetic Score (PES/WES). The PES evaluation consists of 7 variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue texture and color. Mucosa is evaluated with WES, which consists of 5 variables: tooth shape, volume, color, surface texture, translucency/characterization. The mesial and distal papillas are measured for absence, completeness, incompleteness, while the other variables are measured by comparing them with the contralateral teeth in terms of vertical level (score of 2), small (≤1 mm) discrepancy (score of 1), or large (≥1 mm) discrepancy (score of 0). The maximum score will be 14 for PES and 10 for WES, which will mean a perfect match for soft tissue and hard tissue respectively.	TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive)
patient's satisfaction: VAS scale	Patient satisfaction is analyzed by means of a VAS scale	TO (before the therapy), T1 (1 month after placement of the temporary restoration), T2 (3 months after placement of the temporary restoration), T3 (6 months after placement of the temporary restoration), T4 (1 year after placement of the definitive).
Digital valuation of emergency profile	The prosthetic contour is evaluated with the fingerprint to evaluate the angular width of the emergence profile. The amplitude of the angle evaluated is that formed between the emergence profile (part of the crown in contact with the soft tissues) and the long axis of the tooth. The angle of the emergence profile is evaluated by making a digital impression on the plaster model with the crowns inserted in the prosthetic abutment of the master model, first with the temporary and then with the definitive. The unit of measurement expressed by the digital instrument is always the same so it is a single measurement carried out in two different times.	The angle of the emergence profile is evaluated first with the temporary (T0 first week) and then with the definitive(T1 after 3 month).
Evaluation of the interproximal papilla	Once the final crowns have been cemented, the distance between the point of contact and the interproximal papilla is measured.	gap between the most coronal part of the papilla and the point of contact is measured and re-evaluated at 3 months (t2), 6 months (t3), 12 months (t4)

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous; Prosthesis Failure
• Other Study ID Numbers: BOPT 1 unisr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: we'll set up electronic databases for each patient.
• IPD Sharing Time Frame: in a year and a half, we'd produce the data and leave it available.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No